TENAPANOR HYDROCHLORIDE - Generic Drug Details

What are the generic sources for tenapanor hydrochloride and what is the scope of freedom to operate?

Tenapanor hydrochloride is the generic ingredient in two branded drugs marketed by Ardelyx Inc and is included in two NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tenapanor hydrochloride has eighty-seven patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for TENAPANOR HYDROCHLORIDE

International Patents:	87
US Patents:	7
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	18
What excipients (inactive ingredients) are in TENAPANOR HYDROCHLORIDE?	TENAPANOR HYDROCHLORIDE excipients list
DailyMed Link:	TENAPANOR HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TENAPANOR HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

8,541,448

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

8,541,448

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TENAPANOR HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Kyle Staller, MD, MPH	Phase 4
Ardelyx	Phase 4
Ardelyx	Phase 2/Phase 3

See all TENAPANOR HYDROCHLORIDE clinical trials

Pharmacology for TENAPANOR HYDROCHLORIDE

Drug Class	Sodium-Hydrogen Exchanger 3 Inhibitor
Mechanism of Action	Organic Anion Transporting Polypeptide 2B1 Inhibitors Sodium-Hydrogen Exchanger 3 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TENAPANOR HYDROCHLORIDE

A06AX	Other drugs for constipation
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

US Patents and Regulatory Information for TENAPANOR HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-001	Oct 17, 2023		DISCN	Yes	No
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-001	Oct 17, 2023		DISCN	Yes	No
Ardelyx Inc	IBSRELA	tenapanor hydrochloride	TABLET;ORAL	211801-001	Sep 12, 2019		RX	Yes	Yes	12,016,856		Y	Y
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-002	Oct 17, 2023		RX	Yes	No	8,969,377		Y	Y
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-001	Oct 17, 2023		DISCN	Yes	No	8,541,448		Y	Y
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-002	Oct 17, 2023		RX	Yes	No	10,272,079

International Patents for TENAPANOR HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Canada	2748607	COMPOSES ET PROCEDES D'INHIBITION D'UN ANTIPORT A MEDIATION PAR NHE DANS LE TRAITEMENT DE TROUBLES ASSOCIES A UNE RETENTION DE FLUIDE OU A UNE SURCHARGE DE SEL ET DE TROUBLES DU T RACTUS GASTRO-INTESTINAL (COMPOUNDS AND METHODS FOR INHIBITING NHE-MEDIATED ANTIPORT IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS)
Hungary	E036405
Japan	2012514009
China	102333759	Compounds and methods for inhibiting nhe-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Slovenia	2384318
Australia	2019204676	NHE3-BINDING COMPOUNDS AND METHODS FOR INHIBITING PHOSPHATE TRANSPORT

TENAPANOR HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tenapanor Hydrochloride

Introduction

Tenapanor hydrochloride, marketed under the brand names IBSRELA and XPHOZAH, is a significant drug developed by Ardelyx, Inc. It addresses unmet needs in two primary areas: irritable bowel syndrome with constipation (IBS-C) and hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Opportunity

IBS-C Market

The market for IBS-C is substantial, with approximately 4.4 million individuals in the United States suffering from this condition. IBSRELA, the first commercialized product of Ardelyx, has been gaining traction since its launch, capitalizing on this large patient population[3].

Hyperphosphatemia Market

For hyperphosphatemia, the market is equally promising, with around 270,000 patients in the United States who have CKD-5D. The global market for phosphate binders, the only approved therapies for hyperphosphatemia, was projected to reach $2.3 billion by 2015, indicating a robust demand for effective treatments[3].

Commercial Performance of IBSRELA

Quarterly Growth

IBSRELA has demonstrated consistent quarter-over-quarter growth since its launch. In the third quarter of 2023, it achieved $22.3 million in U.S. net sales revenue, representing a 22% increase from the second quarter of 2023. This growth is driven by increased demand, new and repeat prescriptions, and expanded promotional efforts[2][5].

Full-Year Revenue Guidance

For 2023, Ardelyx guided full-year U.S. net product sales revenue for IBSRELA to be between $72 million and $77 million. This guidance reflects the drug's strong market acceptance and the company's efforts to expand its sales team, promotional programming, and patient support services[2][5].

Peak Sales Expectations

Ardelyx expects IBSRELA to achieve greater than 10% market share at peak and generate more than $1 billion in annual U.S. net product sales revenue before patent term expiration. This optimistic outlook underscores the drug's potential for long-term financial success[1].

Commercial Launch and Performance of XPHOZAH

FDA Approval and Launch

XPHOZAH received FDA approval on October 17, 2023, and was launched in November 2023. The initial response from the nephrology community has been positive, with U.S. net product sales revenue for the first quarter of commercialization expected to be approximately $2.5 million[1][2].

Market Reception

The strong initial response to XPHOZAH indicates a promising start for this new medication. Ardelyx is focused on driving awareness and adoption, establishing XPHOZAH's role in the hyperphosphatemia treatment paradigm[1].

Financial Performance and Guidance

Revenue Streams

In addition to product sales, Ardelyx generates revenue from licensing agreements and product supply. For example, in the third quarter of 2023, the company received $32 million in licensing revenue, including milestone payments from Kyowa Kirin and Fosun Pharma[2].

Cash Position

As of December 31, 2023, Ardelyx had a strong cash position with total cash, cash equivalents, and short-term investments of approximately $184 million. This financial stability supports the company's ongoing commercialization efforts and research and development activities[1].

Research and Development Expenses

Research and development expenses have been increasing due to clinical trial and pharmacovigilance activities related to IBSRELA and XPHOZAH. In the third quarter of 2023, R&D expenses were $8.6 million, up from $7.5 million in the same period of 2022[2].

Selling, General, and Administrative Expenses

SG&A expenses have also risen, primarily due to the ongoing commercialization of IBSRELA and preparations for the launch of XPHOZAH. In the third quarter of 2023, SG&A expenses were $32.7 million, an increase of $14 million from the same period in 2022[2].

International Expansion and Partnerships

Global Market Presence

Ardelyx is expanding its global footprint through partnerships and regulatory approvals. For instance, an NDA for tenapanor was accepted for review in China, triggering a $2 million milestone payment. A potential approval in China is expected by the end of 2024[4].

Collaboration Agreements

The company has significant collaboration agreements, including those with Kyowa Kirin and Fosun Pharma, which provide non-dilutive funding and support for the global development and commercialization of tenapanor[2][4].

Future Outlook

Growth Strategy

Ardelyx plans to continue growing sales of its marketed therapies while advancing its business through investments in internal R&D programs, international expansion, and external partnerships. The company aims to shape the future of Ardelyx by leveraging its technological capabilities and expanding its product pipeline[1].

Market Domination

With IBSRELA and XPHOZAH, Ardelyx is well-positioned to dominate the markets for IBS-C and hyperphosphatemia. The company's focus on patient services, omnichannel digital capabilities, and expanded support programs will further enhance its market presence[1].

Key Takeaways

• Strong Commercial Performance: IBSRELA has shown consistent quarter-over-quarter growth, with full-year 2023 revenue guidance between $72 million and $77 million.
• Positive Initial Response to XPHOZAH: The launch of XPHOZAH has been met with a positive response, indicating a promising start in the hyperphosphatemia market.
• Robust Financial Position: Ardelyx maintains a strong cash position, supporting ongoing commercial and R&D activities.
• International Expansion: The company is expanding globally through regulatory approvals and partnerships.
• Long-Term Growth Potential: IBSRELA is expected to achieve over $1 billion in annual U.S. net product sales revenue before patent term expiration.

FAQs

Q: What are the primary indications for tenapanor hydrochloride?

A: Tenapanor hydrochloride is indicated for irritable bowel syndrome with constipation (IBS-C) under the brand name IBSRELA and for hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis under the brand name XPHOZAH.

Q: What is the expected full-year 2024 revenue for IBSRELA?

A: Ardelyx expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $140 million and $150 million[1].

Q: How has XPHOZAH performed since its launch?

A: XPHOZAH received FDA approval in October 2023 and was launched in November 2023. The initial response has been positive, with U.S. net product sales revenue for the first quarter of commercialization expected to be approximately $2.5 million[1].

Q: What is the global market potential for tenapanor?

A: The global market for phosphate binders, relevant to XPHOZAH, was projected to reach $2.3 billion by 2015. Additionally, the IBS-C market in the U.S. includes approximately 4.4 million patients[3].

Q: How is Ardelyx expanding its global presence?

A: Ardelyx is expanding globally through regulatory approvals, such as the NDA acceptance in China, and partnerships with companies like Kyowa Kirin and Fosun Pharma[4].

Sources

1. Ardelyx Provides Update on Growing Commercial Momentum and 2024 Guidance. Ardelyx, Inc.
2. Ardelyx Reports Third Quarter 2023 Financial Results and Updates 2023 U.S. IBSRELA Net Sales Revenue Guidance. BioSpace.
3. Ardelyx, Inc.. Ardelyx, Inc.
4. Ardelyx Reports Second Quarter 2023 Financial Results and Provides 2023 IBSRELA Net Sales Revenue Guidance. BioSpace.
5. Ardelyx Reports Second Quarter 2023 Financial Results. Ardelyx, Inc.